Subarachnoid HemorrhageNCT04311840
Impact of Nimodipine on Sublingual Microcirculation in Patients With Hemorrhage - a Prospective Monocentric Observational Study
An observational study of Subarachnoid Hemorrhage, run by University Hospital Hradec Kralove at 1 site in Czechia.
Trial summary
Nimodipine can increase Functional Capillary Density (FCD) as a parameter of the sublingual microcirculation in patients with subarachnoid hemorrhage (SAH) compared to patients without nimodipine. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Subarachnoid Hemorrhage
- How many people
- 30 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Nov 2019to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All adult patients admitted to the neurosurgical ICU with the diagnosis of subarachnoid hemorrhage. Might be alert, somnolent or sedated on mechanical ventilation. Might be after endovascular coiling or surgical clipping of the aneurysm.
Who may be able to join
- adulthood
- ICU admission
- diagnosis of non-traumatic subarachnoid hemorrhage
Who cannot join
- inherited coagulation disorder
- rheumatic disease
- microangiopathy
- patient of representative refusal
Trial locations and contacts
1 site in 1 country.
Czechia1 site, 1 recruiting
- Recruiting
University Hospital Hradec Kralove
Hradec Králové, Třebeš, 50005
Pavel Dostal, M.D., Ph.D., MBA, +420495833218, karim@fnhk.cz
About this study
Official title: Impact of Nimodipine on Sublingual Microcirculation in Patients With Subarachnoid Hemorrhage - a Prospective Monocentric Observational Study
Nimodipine can increase Functional Capillary Density (FCD) as a parameter of the sublingual microcirculation in patients with subarachnoid hemorrhage (SAH) compared to patients without nimodipine.
Read the detailed description
SAH group - in patients with SAH and documented vasospasms by digital subtraction angiography (DSA) of trans-cranial doppler imaging (TCD) of arteria cerebri media nimodipine is indicated because it is proven to improve the clinical outcome. The disfunction of cerebral microcirculation in rats with SAH has been documented [1-6]. Changes in sublingual microcirculation in patients with SAH with documented vasospasms with nimodipine has not been described.
- Conditions
- Subarachnoid Hemorrhage
- Keywords
- nimodipine, sublingual microcirculation, Side-stream Dark Field imaging
- Medical subject headings
- Subarachnoid Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| SAH patients with nimodipine | Patients with SAH receiving nimodipine as prevention of vasospasms and as a nootropic drug. | |
| SAH patients without nimodipine | Patients with SAH not receiving nimodipine as prevention of vasospasms and as a nootropic drug or in whom the drug has been temporarily discontinued. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional capillary density (FCD)
Parameter describing the perfusion of the microcirculation
Measured: One week
Proportion of perfused vessels (PPV)
Parameter describing the perfusion of the microcirculation
Measured: One week
Secondary outcomes (2)
Vasospasm occurence
Occurence of vasospasms on angiography and/or transcranial Doppler
Measured: One week
Circulatory incoherence
Deranged microcirculation in patients on catecholamines
Measured: One week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2020
- Study start1 Nov 2019
- Primary completion31 Oct 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subarachnoid HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Hradec Kralove
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04311840
- Sponsor's protocol ID
- SAH_Nimodipine
- Status last verified
- Sep 2022
- First submitted
- 18 Nov 2019
- Last updated
- 27 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Nimodipine on Sublingual Microcirculation in Patients With Subarachnoid Hemorrhage - a Prospective Monocentric Observational Study
- ClinicalTrials.gov ID
- NCT04311840
- Acronym / sponsor ID
- SAH_Nimodipine
- Conditions
- Subarachnoid Hemorrhage
- Keywords
- nimodipine, sublingual microcirculation, Side-stream Dark Field imaging
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital Hradec KraloveUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 31 Oct 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 17 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Nimodipine can increase Functional Capillary Density (FCD) as a parameter of the sublingual microcirculation in patients with subarachnoid hemorrhage (SAH) compared to patients without nimodipine.
Detailed description
SAH group - in patients with SAH and documented vasospasms by digital subtraction angiography (DSA) of trans-cranial doppler imaging (TCD) of arteria cerebri media nimodipine is indicated because it is proven to improve the clinical outcome. The disfunction of cerebral microcirculation in rats with SAH has been documented [1-6]. Changes in sublingual microcirculation in patients with SAH with documented vasospasms with nimodipine has not been described.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SAH patients with nimodipine | – | –Patients with SAH receiving nimodipine as prevention of vasospasms and as a nootropic drug. |
| SAH patients without nimodipine | – | –Patients with SAH not receiving nimodipine as prevention of vasospasms and as a nootropic drug or in whom the drug has been temporarily discontinued. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All adult patients admitted to the neurosurgical ICU with the diagnosis of subarachnoid hemorrhage. Might be alert, somnolent or sedated on mechanical ventilation. Might be after endovascular coiling or surgical clipping of the aneurysm.
Key inclusion criteria (3 listed)
- adulthood
- ICU admission
- diagnosis of non-traumatic subarachnoid hemorrhage
Key exclusion criteria (4 listed)
- inherited coagulation disorder
- rheumatic disease
- microangiopathy
- patient of representative refusal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Functional capillary density (FCD)
Time frame: One week
Parameter describing the perfusion of the microcirculation
Proportion of perfused vessels (PPV)
Time frame: One week
Parameter describing the perfusion of the microcirculation
2 secondary outcomes
Vasospasm occurence
Time frame: One week
Circulatory incoherence
Time frame: One week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Subarachnoid Hemorrhage, run by University Hospital Hradec Kralove at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David Astapenko, M.D., Ph.D. (+420608177374, david.astapenko@fnhk.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional capillary density (FCD) (time frame: One week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2022.